CDSCO License for Newborn-infant bed
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn.
Comprehensive Guide to CDSCO Licensing for Newborn-Infant Bed (Class A Medical Device)
As a dedicated regulatory consultancy with over 25 years of experience and having successfully supported 500+ companies in navigating India's medical device regulatory landscape, we bring you an authoritative guide to obtaining a CDSCO license for your Newborn-Infant Bed. This pediatric and neonatology device, classified as Class A under CDSCO's risk-based framework, requires a clear understanding of compliance pathways to ensure timely market entry and regulatory adherence.
Introduction: Understanding the Newborn-Infant Bed and Its Regulatory Importance
The Newborn-Infant Bed is a critical medical device designed specifically for neonatal care. Typically, it is an open rectangular receptacle mounted on a wheeled trolley framework, padded with appropriate bedding to provide a safe and comfortable environment for newborns. Sometimes, additional heating elements are integrated to maintain optimal infant body temperature.
Given its use in sensitive neonatal care settings, even though it’s classified as Class A (low risk), adherence to medical device regulations by the Central Drugs Standard Control Organisation (CDSCO) is mandatory for manufacturers and importers. Compliance ensures that the device meets safety, quality, and performance standards, vital for patient safety and hospital acceptance.
CDSCO Regulatory Framework for Newborn-Infant Beds
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, which categorizes devices into four risk classes (A, B, C, D). Newborn-Infant Beds fall under Class A, the lowest risk category, but still require a manufacturing license (MD5) from the State Licensing Authority.
Manufacturers must comply with:
- Medical Device Rules, 2017
- Essential Principles of Safety and Performance
- Quality Management System standards (ISO 13485 recommended)
For detailed classification guidance, manufacturers can refer to the Medical Device Classification resource.
Risk Classification and License Requirements for Newborn-Infant Beds
- Risk Class: A (Low risk)
- License Type: MD5 Manufacturing License
- Regulatory Authority: State Licensing Authority
- Application Form: MD3
- Additional Requirements: Test License (MD13) prior to MD5 application
Class A devices like the Newborn-Infant Bed require a phased approach starting with a Test License, followed by product testing, and finally the manufacturing license application.
Manufacturing License Process (MD5) for Newborn-Infant Bed
The MD5 manufacturing license process involves several key steps:
Obtain Test License (Form MD13): This initial license allows you to legally manufacture the device for testing purposes. It typically takes 1.5 to 2 months to obtain.
Product Testing: Conduct mandatory product testing at CDSCO-approved government laboratories. This is crucial for demonstrating compliance with device standards. A list of Testing Laboratories can be accessed online.
Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
Submit MD5 Application (Form MD3): File your manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct a thorough audit of your manufacturing facility. You can check the list of notified bodies authorized for Class A audits.
Query Resolution: Address any queries or observations raised by the CDSCO or notified body promptly.
Grant of Manufacturing License (Form MD5): Upon successful completion of all steps, the license is granted.
For a detailed walkthrough, consult our MD5 License Guide.
Manufacturing License Documents Required for Newborn-Infant Bed
The documentation is a critical element of your application. For Class A devices, prepare the following:
- Company Constitution: Incorporation certificate, Memorandum & Articles of Association
- Proof of Ownership or Lease of Premises: Rent agreement or ownership documents
- Technical Staff Details: Qualification certificates and experience proof for key personnel
- Fire NOC and Pollution Control NOC: Valid certificates from respective authorities
- Device Master File (DMF): Detailed design, manufacturing, and quality information (Device Master File Guide)
- Plant Master File (PMF): Details of manufacturing facility and equipment (Plant Master File Guide)
- Essential Principles Checklist: Compliance checklist with Indian MDR essential principles
- Risk Management File: Hazard identification and mitigation measures (Risk Management)
- Test Reports: Product testing certificates from CDSCO-approved labs
- Labels and Instructions for Use (IFU): Samples conforming to regulatory standards
- Quality Management System Documents: ISO 13485 certification and internal SOPs
Import License Process (MD15) for Newborn-Infant Bed
If you plan to import Newborn-Infant Beds into India, an Import License (MD15) issued by the Central Licensing Authority is required. However, since this device is Class A, import fees and procedures are relatively straightforward.
Key steps:
Document Preparation: Includes Manufacturing License (from the country of origin), Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.
Application Submission: File Form MD14 on the CDSCO MD Online Portal.
Query Resolution: Address any concerns raised by CDSCO promptly.
Grant of Import License: Typically takes 5-6 months.
For a comprehensive guide, see our Import License Guide.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License in India
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Documentation & MD5 Application | 1 month |
| Audit by Notified Body | 2 to 3 weeks |
| Query Resolution | 2 to 4 weeks |
| Total Time for MD5 License | Approx. 3 to 4 months |
For imports, expect 5 to 6 months total processing time.
Government Fees and Costs for Newborn-Infant Bed Licensing
- MD5 Manufacturing License Fees: Rs. 5,000 per application + Rs. 500 per product
- Test License Fees: Included in the above process
- Audit Fees: Payable directly to the notified body (varies by body)
These fees are competitive and reflect the low-risk class of the Newborn-Infant Bed.
Common Challenges and Solutions
Challenge: Delays in product testing due to laboratory backlogs
- Solution: Schedule testing appointments early and ensure all samples meet submission criteria.
Challenge: Incomplete or inconsistent documentation
- Solution: Use detailed checklists and engage professional consultants to review documents before submission.
Challenge: Queries during audit causing delays
- Solution: Prepare your manufacturing facility according to notified body requirements and maintain transparent communication.
Challenge: Understanding complex regulatory terminology
- Solution: Utilize expert guidance and training resources to stay informed.
Expert Consultation and Support
Our team specializes in guiding manufacturers of low-risk medical devices like the Newborn-Infant Bed through every step of the CDSCO licensing journey. From document preparation to audit readiness and query management, we provide actionable insights tailored to your product and business needs.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class A using CDSCO guidelines.
- Prepare Test License Application: Begin with Form MD13 on the CDSCO MD Online Portal.
- Engage Approved Testing Labs: Coordinate testing early to avoid delays.
- Compile Robust Documentation: Utilize our guides for Device and Plant Master Files.
- Schedule Notified Body Audit: Select an authorized body from the Notified Bodies List.
- Submit MD5 Application: Apply through the online portal ensuring completeness.
- Respond Promptly to Queries: Maintain proactive communication with CDSCO officials.
By following these practical steps and leveraging our expertise, you can streamline your compliance process and bring your Newborn-Infant Bed to the Indian market efficiently and confidently.
